Focusing on validation at the outset of medical product development will help avoid delays and frustration in trying to get these products to market, experts warn.
The importance of factoring in validation requirements at the start of the development process will be one of the key themes on which delegates from the medical devices and pharmaceutical sectors will be briefed at a UK microbiology conference taking place on 5th March.
Delegates will hear how the emergence of increasingly complex medical devices, has resulted in regulation and validation requirements becoming more demanding than ever; making it essential for businesses to be fully aware of up-to-date standards before embarking on new development projects.
Jenni Tranter from the Applied Sterilisation Technologies (AST) division of Synergy Health, said: “Functionality and saleability understandably, are primary concerns of businesses developing medical or pharmaceutical products.
“But, in an increasingly complex regulatory environment, it’s more important than ever that validation processes are understood and considered from an early stage. This is particularly relevant for smaller companies developing cutting-edge health technology that don’t have their own in-house sterilisation validation experts or testing facilities. This event will help increase their awareness of the challenges they face and how to address them in a practical way.
"Crucially, the day will also focus on specific challenges in action, offering case studies of success stories and instances where problems in device development have had to be overcome,” she added.
During the conference specialists from Synergy Health, Pall Life Sciences, Associates of Cape Cod (ACC), Meddiquest and Anecto will outline all elements of the validation process, including sterilisation technologies, ISO standards, packaging, accelerated aging, validation microbiology and endotoxin testing.
Conference workshops will also demonstrate how to overcome challenges in areas such as, devising a sampling plan for endotoxin testing, validating product families, developing a medical device and embarking on packaging and age-testing activities.